Cell and Tissue Banking

, Volume 9, Issue 2, pp 121–137 | Cite as

Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

Review Paper

Abstract

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP’s which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, “financial gain” and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

Keywords

Brain/Tissue/Bio banking Code of Conduct Donors Ethics Financial gain Funding Genetic testing Informed consent Safety Sharing 

Abbreviations

AD

Alzhemiers disease

BTB

Banks—Brain/tissue/Bio banks

EBBN

European Brain Bank Network

SOP

Standard Operating Procedure

MTA

Material Transfer Agreement

QMS

Quality Management System

TubaFrost

European Human Frozen Tumour Tissue Bank

References

  1. Alafuzoff I, Pikkarainen M, Al-Sarraj S, Arzberger T, Bell J, Bodi L, Bogdanovic N, Budka H, Bugiani O, Ferrer I, Geipi E, Giaccone G, Graeber MB, Hauw JJ, Kamphorst W, King A, Kopp N, Korkolopoulou P, Kovacs CG, Meyronet D, Parchi P, Patsouris E, Preusser M, Ravid R, Roggendorf W, Seilhean D, Streichenberger N, Thal DR, Kretzschmar H (2006) Interlaboratory comparison of assessments of Alzheimer disease-related lesions: a study of the BrainNet Europe Consortium. J Neuropathol Exp Neurol 65(8):740–757PubMedGoogle Scholar
  2. American Neurological Association Council on Ethical and Judicial Affairs (1999) Medical futility in end-of-life care: report of the Council on Ethical and Judicial Affairs. JAMA 281:937–941CrossRefGoogle Scholar
  3. Anderson R, Balls M, Burke MD, Cummins M, Fehily D, Gray N, De Groot MG, Helin H, Hunt C, Jones D, Price D, Richert L, Ravid R, Shute D, Sladowski D, Stone H, Thasler W, Trafford J, van der Valk J, Weiss T, Womack C, Ylikomi T (2001) The establishment of human research tissue banking in the UK and several western European countries: the report and recommendations of ecvam workshop 44. Altern Lab Anim 29(2):125–134PubMedGoogle Scholar
  4. Baker R (2005) A draft model aggregated code of ethics for bioethicist. Am J Bioeth 5:33–41PubMedGoogle Scholar
  5. Barnes M, Heffernan K (2004) The future uses dilemma: secondary uses of data and materials by researchers and commercial research sponsors. Med Res Law Policy 3:440–452Google Scholar
  6. Baeyens AJ, Hakimian R, Aamodt R, Spatz A (2002) The use of human biological samples in research; a comparison of the laws in the United states and Europe. Biosci Law Rev 5(5):155–160Google Scholar
  7. Beaulieu A (2004) From brain bank to database: the informational turn in the study of the brain. Stud Hist Philos Biol Biomed Sci 35:367–390CrossRefGoogle Scholar
  8. Bell J, Ironside J (1997) Principles and practice of “high risk” brain banking. Neuropathol Appl Neurobiol 23:281–288PubMedCrossRefGoogle Scholar
  9. Bernat JL, Peterson LM (2006) Patient-centred informed consent in surgical practice. Arch Surg 141(1):86–92PubMedCrossRefGoogle Scholar
  10. Bidaut-Russell M, Ravid R, Cruz-Sánchez FF, Grossberg GT, McKeel DW (1995) Survey of North American and European dementia brain banks: a 1994 directory. Alzheimer’s Dis Relat Disord 9(4):193–202Google Scholar
  11. Borry P, Schotsmans P, Dierickx K (2006) How international is bioethics? Quantitative retrospective study. BMC Med Ethics 7:E1PubMedCrossRefGoogle Scholar
  12. British Mediacl Association (1996) BMA guidelines on treatment decisions for patients in persistent vegetative states. British Medical Association, LondonGoogle Scholar
  13. Cambon-Thomsen A (2004) The social and ethical issues of post-genomic human bio banks. Nat Rev Genet 5(11):866–873PubMedCrossRefGoogle Scholar
  14. Cassel C (1985) Research on senile dementia of the Alzheimer type; ethical issues involving informed consent. In: Melinick VL, Dubler NN (eds) Alzheimer’s dementia. The Human Press ic., Clifton, pp 99–108Google Scholar
  15. Cassel CK (1998) Genetic testing and Alzheimer’s disease; ethical issues for providers and families. Alzheimer Dis Assoc Disord 12(Suppl 3):S16–S20PubMedGoogle Scholar
  16. Caulfield T (2004) Tissue banking, patient rights, and confidentiality: tensions in law and policy. Med Law 23:39–49PubMedGoogle Scholar
  17. CIOMS/WHO (1993) International Ethical Guidelines for Biomedical Research Involving Human Subjects. In: Bankowski Z (ed) ISBN 92 9036 056 9. Sw.fr. 10Google Scholar
  18. Clayton EW (2005) Informed consent and bio banks. J Law Med Ethics 33(1):15–21PubMedCrossRefGoogle Scholar
  19. Council of Europe Convention; Universal declaration, Ministers’ Deputies; CM Documents CM (2005) 56 final 13 May 2005Google Scholar
  20. Council of Europe (1994). Draft convention for the protection of human rights and dignity of the human being; bioethics convention and explanatory memorandum. Directorate of Legal Affairs, European UnionGoogle Scholar
  21. Council of Europe (2006) Recommendation of the committee of Ministers to member states on research on biological materials of human origin (958th meeting of the Minister’s deputies)Google Scholar
  22. Council of Europe Convention; Universal declaration, Ministers’ Deputies; CM Documents CM (2005) 56 final 13 May 2005Google Scholar
  23. Cruz-Sánchez FF, Tolosa E (1993) The need of a consensus for brain banking. J Neural Transm 39(suppl):1–4Google Scholar
  24. Cruz-Sánchez FF, Ravid R, Cuzner ML (1995) The European Brain Bank Network (EBBN) and the need of standardized neuropathological criteria for brain tissue cataloguing. In: Cruz-Sánchez FF, Cuzner ML, Ravid R (eds) Neuropathological diagnostic criteria for brain banking, European union biomedical and health research, vol 10. IOS Press, Amsterdam, pp 1–3Google Scholar
  25. Cruz-Sánchez FF, Mordini E, Ravid R (1997) Ethical aspects to be considered in brain banking. Annali dell’Istituto Superiore di Sanità 33:477–482PubMedGoogle Scholar
  26. Declaration of Helsinki (1964) Ethical principles for medical research involving human subjects. Adopted by the 18th World medical Assembly. Helsinki, FinlandGoogle Scholar
  27. Declaration of Helsinki (Edinburgh 2000) World Medicine Association. 52nd WMA General Assembly, Edinburgh, Scotland. Available at http://www.wma.net. Accessed Oct 2000
  28. Dickens BM, Pei N, Taylor KM (1996) Legal and ethical issues in genetic testing and counselling for susceptibility to breast, ovarian and colon cancer. CMAJ 154:813–818PubMedGoogle Scholar
  29. Duyckaerts C, Delaere P, Hauw JJ, Abbamondi-Pinto NL, Sorbi S, Allen I, Brion JP, Flament-Durand J, Duchen L, Kauss J (1990) Rating of the lesions in senile dementia of the Alzheimer type: concordance between laboratories. A European multicenter study under the auspices of EURAGE. J Neurol Sci 97:295–323PubMedCrossRefGoogle Scholar
  30. European Directive on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, EC 2001/20, L 121, 01/05/2001 P. 0034–0044Google Scholar
  31. European Directive 2004/23/EC of the European Parliament and the European Commission on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cellsGoogle Scholar
  32. Ferrer I, Armstrong J, Parchi P, Capellari S, Arzberger T, Bell J, Budka H, Ströbel T, Giaccone G, Bogdanovich N, Fakai P, Riederer P, Al-Sarraj S, Ravid R, Kretzschmar H (2007) Effects of formalin fixation, paraffin embedding, and time of storage on DNA preservation in brain tissue: a BrainNet Europe study. Brain Pathol 17(3):297–303PubMedCrossRefGoogle Scholar
  33. Fulford B, Mordini E (1994) Informed consent in psychiatry: cross cultural and philosophical issues. Bull Med Ethics 103:22–24PubMedGoogle Scholar
  34. Furness PN (2001) Research using human tissues—a crisis of supply? J Pathol 195:277–284PubMedCrossRefGoogle Scholar
  35. Gindro S, Mordini E (1998) Ethical, legal and social issues in brain research. Curr Opin Psychiatry 11(5):575–580Google Scholar
  36. Godard B, Schmidtke J, Cassiman JJ, Ayme S (2003) Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Eur J Hum Genet 11(suppl 2):S88–122PubMedCrossRefGoogle Scholar
  37. Gray N, Womack C, Jack SJ (1999) Supplying commercial biomedical companies from a human tissue bank in an NHS hospital—a view from personal experience. J Clin Pathol 52:254–256PubMedCrossRefGoogle Scholar
  38. Hakimian R (2000) Disclosure of Huntington’s disease to family members: the dilemma of known but unknowing parties. Genet Test 4:359–364PubMedCrossRefGoogle Scholar
  39. Hakimian R, Korn D (2004) Ownership and use of tissue specimens for research. JAMA 292:2500–2505PubMedCrossRefGoogle Scholar
  40. Harris J (2002) Law and regulation of retained organs; the ethical issues. Leg Stud 22(4):527–549CrossRefGoogle Scholar
  41. Human Tissue Act (2004) UK (ISBN 0 10 543004 8)Google Scholar
  42. Human Tissue Authority (2006) The removal, storage and disposal of human organs and tissue, Code of practiceGoogle Scholar
  43. Human Tissue (Scotland) Act 2006 The Bill for this Act of the Scottish Parliament was passed by the Parliament on 2nd February 2006 and received Royal Assent on 16th March 2006Google Scholar
  44. Holm S (2002) Ethics committees in Northern Europe. Not Polit 18:54–59Google Scholar
  45. Holm S (2006) The WMA on medical ethics; critical comments. J Med Ethics 32:161–162PubMedCrossRefGoogle Scholar
  46. Holm S, Williams-Jones B (2006) Global bioethics—myth or reality? BMC Med Ethics 7:10CrossRefGoogle Scholar
  47. Illes J, Bird SJ (2006) Neuroethics: a modern context for ethics in Neuroscience. Trends Neurosci 29(9):511–517PubMedCrossRefGoogle Scholar
  48. Ironside J, Bell J (1996). The high risk neuropathological autopsy in AIDS and Creutzfeldt-Jakob disease: principles and practice. Neuropathol Appl Neurobiol 22:388–393PubMedGoogle Scholar
  49. Jack LA, Womack C (2003) Why surgical patients do not donate tissue for commercial research. Review records. BMJ 327:262PubMedCrossRefGoogle Scholar
  50. Jacob MA (2006) Another look at the presumed-versus-informed consent dichotomy in post-mortem organ procurement. Bioethics 20:293CrossRefGoogle Scholar
  51. Kass N, Dawson L, Loyo-Berrios NI (2003) Ethical oversight of research in developing countries. IRB 25:1–10PubMedCrossRefGoogle Scholar
  52. Kismodi E, Hakimian R (2001) A survey of patient’s rights representatives in Israeli hospitals; 1999–2000. Med Law 20(1):17–36PubMedGoogle Scholar
  53. Knoppers BM (2004) Biobanks, simplifying consent. Nat Rev Genet 5(57):485PubMedCrossRefGoogle Scholar
  54. Knoppers BM (2005) Biobanking; international norms. J Law Med Ethics 33(1):7–14PubMedCrossRefGoogle Scholar
  55. Korn D (1999) Genetic testing and the use of information. AEI Press, WashingtonGoogle Scholar
  56. Korn D (2000) Medical information privacy and the conduct of biomedical research Acad Med 75:963–968PubMedCrossRefGoogle Scholar
  57. Lipworth W (2005) Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers. J Law Med 13:245–255PubMedGoogle Scholar
  58. Lopez-Guerrero JA, Riegman PH, Oosterhuis JW, Lam KH, Oomen MH, Spatz A, Ratcliff C, Knox K, Mager R, Kerr D, Pezzela F, Van Damme B, Morente MM, Alonso S, Llombart-Bosch A (2006) TuBaFrost 4: access rules and incentives for a European tumour bank. Eur J Cancer 42(17):2924–2929PubMedCrossRefGoogle Scholar
  59. Mager SR, Oomen MH, Morente MM, Ratcliffe C, Knox K, Kerr DJ, Pezella F, Riegman PH (2007) Standard Operating Procedures for the collection of fresh frozen tissue samples. Eur J Cancer 43(5):828–834PubMedCrossRefGoogle Scholar
  60. Malinowsky MJ (2005) Technology transfer in Biobanking; credits and population health futures. J Law Med Ethics 33(1):54–69CrossRefGoogle Scholar
  61. Mallardi V (2005) The origin of informed consent. Acta Otorhinolaryng. Ital 25(5):312–327Google Scholar
  62. Maschke KJ, Murray TH (2004) Ethical issues in tissue banking for research: the prospects and pitfalls of setting international standards. Theor Med Bioeth 25:143–155PubMedCrossRefGoogle Scholar
  63. Matsumoto I, Niwa SI, Ravid R (2002) Psychiatric brain banks: situation in Europe and Asia. In: Agam G, Belmaker RH, Everall I (eds) The Post-Mortem brain in psychiatric research. Kluwer Academic Publishers, Massachussetts, pp 3–10Google Scholar
  64. Micke P, Ohshima M, Tahmasebpoor S, Ren ZP, Ostman A, Ponten F, Bolting J (2006) Biobanking of fresh frozen tissue:RNA is stable in nonfixed surgical specimens. Lab Invest 86:202–211PubMedCrossRefGoogle Scholar
  65. Molyneux CS, Wassenaar DR, Peshua N, Marsh K (2005) Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!”: community voices on the notion and practice of informed consent for biomedical research in developing countries. Social Sci Med 61:443–454CrossRefGoogle Scholar
  66. Mordini E (1995) Ethical aspects of brain research. Italy J Psychiatry Behav Sci 5(1):35–41Google Scholar
  67. Morente MM (2004) Tissue banks; who decides what is ethical? Eur J Cancer 40(1):5PubMedGoogle Scholar
  68. Morente MM, Mager R, Alonso S, Pezzella F, Spatz A, Knox K, Kerr D, Dinjens WN, Oosterhuis JW, Lam KH, Oomen MH, van Damme B, van de Vijver M, van Boven H, Kerjaschki D, Pammer J, Lopez-Guerrero JA, Llombart Bosch A, Carbone A, Gloghini A, Teodorovic I, Isabelle M, Passioukov A, Lejeune S, Therasse P, van Veen EB, Ratcliffe C, Riegman PH (2006) TuBaFrost 2: standardizing tissue collection and quality control procedures for a European virtual frozen tissue bank network. Eur J Cancer 42(16):2684–2691PubMedCrossRefGoogle Scholar
  69. Nielsen AS Ravid R, Kamphorst W, Jorgensen OS (2003) Apoliprotein E e4 in an autopsy series of various dementing disorders. J Alzheimers Dis 5(2):119–125Google Scholar
  70. Nishimura T (2005) The present state and problems of “The code of Medical Ethics” in Japan. J Int Bioeth 16(1–2):41–50Google Scholar
  71. Novotny TF, Mordini E, Chadwick R, Pedersen JM, Fabbri F, Lie R, Thanachailboot N, Mossialos E, Permanand G (2006) Bioethical implications of globalization: an international consortium project of the European Commission. PLoS Med 3Google Scholar
  72. Nuffield Council on Bioethics (1995) Human tissue: ‘Ethical and Legal issues’., Nuffield Council on Bioethics, London, 155ppGoogle Scholar
  73. Orr S, Alexandre E, Clark B, Combes R, Fels LM, Gray N, Jensson-Rylander AC, Helin H, Koistinen J, Oinonen T, Richert L, Ravid R, Salonen J, Teesalu T, Thasler W, Trafford J, van der Valk J, von Versen R, Weiss T, Womack C, Ylikomi T (2002) The establishment of a network of European human research tissue banks. Cell Tissue Bank 3:133–137PubMedCrossRefGoogle Scholar
  74. Padley D, Fergusin M, Warwick RM, Womack C, Lucas SB, Saldanha J (2005) Challenges in the testing of non-heart beating cadavers for viral markers; implications for the safety of tissue donors. Cell Tissue Bank 6(3):171–179PubMedCrossRefGoogle Scholar
  75. Page AK (2004) Ethical issues in international biomedical research: an overview. J Health Law 37:629–665PubMedGoogle Scholar
  76. Pauwels E (2007) European commission; ethics for researchers; facilitating research excellence in FP7. Available at http://www.europa.eu.int/comm/research/science-society
  77. Post SG, Whitehouse PJ, Binstock RH, Bird TD, Eckert SK, Farrer LA, Fleck LM, Gaines AD, Juengst ET, Karlinsky H, Miles S, Murray TH, Quaid KA, Relkin NR, Roses AD, St. George-Hyslop PH, Sachs GA, Steinbock B, Truschke EF, Zinn AB (1997) The clinical introduction of genetic testing for Alzheimer disease. JAMA 277:832–836PubMedCrossRefGoogle Scholar
  78. Ravid R (1992a) Disclosure of mental illness to employers: legal resources and ramifications. J Psychiatry Law 20:85–102Google Scholar
  79. Ravid R (1992b) Legal and legislative trends in drug testing. J Psychiatry Law 19:281–294Google Scholar
  80. Ravid R (2002) Methodological considerations of the establishment of a brain bank for psychiatric research; The Amsterdam and European experience. In: Agam G, Belmaker RH, Everall I (eds) The post-mortem brain in psychiatric research. Kluwer Academic Publishers, Massacchusettes, USAGoogle Scholar
  81. Ravid R, Menon S (1993) Guidelines for disclosure of patient information under the Americans with disabilities Act. Hosp Community Psychiatry 44(3):280–281PubMedGoogle Scholar
  82. Ravid R, Swaab DF (1993) The Netherlands Brain Bank; a clinico-pathological link in aging and dementia research. J Neural Transm Suppl 39:143–153PubMedGoogle Scholar
  83. Ravid R, Swaab DF (1995) Brain Banking in Alzheimer's disease: pitfalls and potentials. J Neuropath Appl Neurobiol 21(Suppl 1):18–19Google Scholar
  84. Ravid R, Winblad B (1993) Brain banking in Alzheimer’s disease: factors to match for, pitfalls and potentials. In: Corain B, Iqbal K, Nicolini M, Winblad B, Wisniewski H, Zatta P (eds) Alzheimer's disease: Advances in clinical and basic research. John Wiley & Sons, Sussex, UK, pp 213–218Google Scholar
  85. Ravid R, van Zwieten EJ, Swaab DF (1992) Brain banking and the human hypothalamus – factors to match for, pitfalls and potentials. In: Swaab DF, Hofman MA, Mirmiran M, Ravid R, Van Leeuwen FW (eds) Progress in brain research. The human hypothalamus in health and disease, vol 93. Elsevier, Amsterdam pp 83–95Google Scholar
  86. Ravid R, Swaab DF, Kamphorst W, Van Zwieten EJ (1995a) A golden standard protocol for the brain banking society? The Amsterdam Experience. J Neuropathol Exp Neurol 54(Suppl 25):26SGoogle Scholar
  87. Ravid R, Swaab DF, Van Zwieten EJ, Salehi A (1995b) Controls are what makes a brain bank go round. In: Cruz-Sanchez FF, Ravid R, Cuzner ML (eds) Neuropathological diagnostic criteria for brain banking. IOS Press, Amsterdam, pp 4–13Google Scholar
  88. Ravid R, Swaab DF, Kamphorst W, Salehi A (1998) Brain banking in aging and dementia research. The Amsterdam experience. In: Fisher A, Yorshida M and Hanin I (eds) Progress in Alzheimer’s and Parkinson’s disease. Plenum Press, New York, pp 277–286Google Scholar
  89. Ravid R, Kamphorst W, Kahlmann M, Holtrop A (2001) Brian banking in psychiatric disorders – the Amsterdam experience. In: Myoshi K, Shapiro C, Gaviria M, Morita Y (eds) Contemporary neuropsychiatry. Springer-Verlag Tokyo, pp 326–329Google Scholar
  90. Reymond MA, Steinert R, Escourrou J, Fourtanier G (2002) Ethical, legal and economic issues raised by the use of human tissue in post genomic research. Dig Dis 20:257–265PubMedCrossRefGoogle Scholar
  91. Riegman PH, Dijen WN, Oomen MH, Mager R, Oosterhuis JW (2006) TuBaFrost 1: uniting local frozen Tumour banks into a European network; an overview. Eur J Cancer 42(16):2678–2683PubMedCrossRefGoogle Scholar
  92. Roses AD (1998) Genetic testing and Alzheimer disease: the promise. Alz Dis Assoc Dis 12(3):S3–S9Google Scholar
  93. Royal College of Pathologists (2001) Transitional guidelines to facilitate changes in procedures for handling ‘surplas’ and archival material from human biological samples. Royal College of Pathologists, London http://www.rcpath.org/activities/publications/transitional.html [22 May 2002]
  94. Salai M, Vonsover A, Pritch M, von Versen R, Horoszowski H (1997). Human immunodeficiency virus (HIV) inactivation of banked bone by gamma irradiation. Ann Transplant 2(1):55–56PubMedGoogle Scholar
  95. Sampogna (2006) Creation and governance of human genetic research databases. OECD 9–17Google Scholar
  96. Schmitt A, Bauer M, Heinsen H, Feiden W, The Consortium of BrainNet Europe II, Falkai P, Alafuzoff I, Arzberger T, Al-Sarraj S, Bell JE, Bogdanovic N, Bruck W, Budka H, Ferrer I, Giaccone G, Kovacs GG, Meyronet D, Palkovits M, Parchi P, Patsouris E, Ravid R, Reynolds R, Riederer P, Roggendorf W, Schwalber A, Seilhean D, Kretzschmar H (2007) How a neuropsychiatry brain bank should be run: a consensus paper of BrainNet Europe II. J Neural Transm 114(5):527–537Google Scholar
  97. Snyder L, Leffler C (2005) Ethics and human rights committee, American College of Physicians. Ann Int Med 142:560–582PubMedGoogle Scholar
  98. Tenenholz-Grinberg L, De Lucena Ferretti RE, Farfel JM, Leite R, Pasqualucci CA, Rosemberg S, Nitrini R, Nascimento Saldiva PH, Filho WJ, Brazilian Aging Brain Study Group (2006) Brain bank of the Brazilian aging brain study group—a milestone reached and more than 1,600 collected brains. Cell Tissue Bank 82(2):151–162Google Scholar
  99. Thoret Y, Kantin S (1994) Historical development of legal protection for the rights of mentally ill persons in France. Hosp Community Psychiatry 45(12):1211–1214PubMedGoogle Scholar
  100. Tully J, Ninis N, Booy R, Viner R (2000) The new system of review by multicentre research ethics committees; prospective study. BMHJ 320(7243):1179–1182Google Scholar
  101. Universal declaration on Bioethics and human rights adopted by UNESCO’s General Conference 19.10.2005. Available at http://www.unesco.org
  102. Van Swieten JC, Bronner IF, Azmani A, Severijnen LA, Kamphorst W, Ravid R, Rizzu P, Willemsen R, Heutink P (2007) The DeltaK280 mutation in MAP tau favors exon 10 skipping in vivo. J Neuropathol Exp Neurol 66(1):17–25PubMedCrossRefGoogle Scholar
  103. Van Veen EB, Riegman PH, Dinjens WN, Lam KH, Oomen MH, Spatz A, Mager R, Ratcliffe C, Knox K, Kerr D, Van Damme B, Van de Vijver M, Van Boven H, Morente MM, Alonso S, Kerjaschki D, Pammer J, Lopez-Guerrero JA, Liombart Bosch A, Carbone A, Gloghini A, Teodorovic I, Isabelle M, Passioukov A, Lejeune S, Therasse P, Oosterhuis JW (2006) TuBaFrost 3: regulatory and ethical issues on the exchange of residual tissue for research across Europe. Eur J Cancer 42:2914–2923PubMedCrossRefGoogle Scholar
  104. Von Versen R (1999) Musculoskeletal tissue banking in Europe—regulations and quality assurance. Ann Chir Gynaecol 88(3):215–220Google Scholar
  105. Von Versen R, Monig HJ, Salai M, Bettin D (2000) Quality issues in tissue banking: quality management systems—a review. Cell Tissue Bank 1(3):181–192CrossRefGoogle Scholar
  106. Whitehouse PJ (2003) The rebirth of bioethics: extending the original formulations of Van Rensselaer Potter. Am J Bioeth 3:W26–W31PubMedGoogle Scholar
  107. Whitehouse PJ (2006) Quality of life: the bridge from the cholinergic basal forebrain to cognitive science and bioethics. Alzheimer’s Dis 9:447–453Google Scholar
  108. Winickoff DE, Winickoff RN (2003) The charitable trust as a model for genomic bio banks. N Engl J Med 349:1180–1184PubMedCrossRefGoogle Scholar
  109. Womack C (2002) Ethical issues relating to supply of human tissue to the commercial biomedical sector. Cell Tissue Bank 3:203–209PubMedCrossRefGoogle Scholar
  110. Womack C (2006) Supply and use of human tissue for research purposes: survey of BATB affiliated tissue banks. Cell Tissue Bank 7(3):207–209PubMedCrossRefGoogle Scholar
  111. Womack C, Gray NM (2000) Human research tissue banks in the UK National Health Service: law, ethics, controls and constraints. Br J Biomed Sci 55:250–253Google Scholar
  112. Womack C, Gray N, Aikens J, Jack A (2000) The Peterborough hospital human tissue bank. ATLA 28:259–270Google Scholar
  113. Womack C, Gray NM, Pearson JE, Fehily D (2001) Cadaveric tissue supply to the commercial sector for research: collaboration between NHS pathology and NBS tissue services extending the options for donors. Cell Tissue Bank 2:51–55PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2007

Authors and Affiliations

  1. 1.Netherlands Institute for NeurosciencesRoyal Dutch Academy of ScienceAmsterdamThe Netherlands

Personalised recommendations